High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)

NCT03954431 | Recruiting DMC FDA Device

• 2 other identifiers: 1903399639R01CA199044
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being performed to find out if a new kind of breast imaging (called dedicated breast CT or BCT) can help doctors to see the small structures in breast tissue more clearly. The investigators also want to find out if using the BCT will provide a more accurate diagnosis of breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  The diagnostic accuracy of BCT will be determined from a multi-reader, multi-case reader study.

  12 months after completion of accrual

Study Arms (1)

Dedicated breast computed tomography (BCT)

EXPERIMENTAL

All subjects will undergo bilateral breast CT (BCT) imaging exam.

Diagnostic Test: Dedicated breast CT(BCT)

Interventions

Dedicated breast CT(BCT) DIAGNOSTIC_TEST

The breast CT device will take multiple pictures of the subject's uncompressed breast and creates a 3-D image of the breast.

Also known as: BCT

Dedicated breast computed tomography (BCT)

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who are 40 years of age or older (typical screening age range)
• who are undergoing or scheduled for screening or diagnostic imaging, or need a biopsy to investigate an abnormality in the breast.

You may not qualify if:

• Males,
• women less than 40 years old,
• women unable to self-consent,
• prisoners,
• pregnant, suspected to be pregnant, or lactating women (self-reported)
• women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker;
• women who are unable to tolerate study constraints, frail, or unable to cooperate;
• women who weigh more than 440 lbs (200 Kg), which is the weight limit for the patient support table of the BCT system;
• women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) treatment for enlarged thymus gland as an infant, irradiation for benign breast conditions, including breast inflammation after giving birth, and treatment for Hodgkin's disease;
• women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram;
• women who have received large number of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Srinivasan Vedantham, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Galvan, R.T.R.

CONTACT

520-626-2279; mngalvan@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will undergo a bilateral breast CT (BCT) exam.

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: August 14, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

US (1)